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Cleanroom Basics - CERHB

UFControlling the environmentCleanroom Basics UFWhat is a Cleanroom ?ISO 14644-1: 'A room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimise the introduction, generation, and retentionof particles & microbes inside the room and in which other relevant parameters, temperature, humidity, and pressure, are controlled as necessary.' UFWho sbeing protected from What?Center of Excellence for Regenerative Health Biotechnology UFProtecting the ProductThe quality of biopharmaceuticals depends on the absence of contamination from beginning to end of the production influenza virusReplicate in cellsMany virus particlesExtensive PurificationInfluenzaVaccine UFContamination Control Environmental Control Atmospheric Materials and supplies Entrance and exit Cleaning and maintenance Personnel Control Activity Personal Hygiene Gowning UFHow Clean?

©UF What is a cleanroom? ISO 14644-1: • 'A room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimise the introduction, generation, and retention of particles & microbes inside the room and in which other relevant parameters, e.g. temperature, humidity, and pressure, are

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